BOSTON--(BUSINESS WIRE)--Aug 1, 2011 - Stealth Peptides Inc.
(Stealth), a privately held biopharmaceutical company developing
innovative mitochondrial therapies for diseases with unmet medical
needs, presented its lead clinical candidate, Bendavia™,
during the 2011 American Heart Association's (AHA) Cardiovascular
Scientific Sessions. Bendavia is a novel compound that targets the
mitochondrion to treat mitochondrial dysfunction including ischemia
reperfusion and microvascular injuries. AHA is a U.S.
non–profit organization that focuses on cardiac care
worldwide with a goal of reducing morbidity and mortality caused by
cardiovascular disease, the leading cause of death worldwide. The
2011 AHA Cardiovascular Scientific Sessions were held July 18th
through 21st, in New Orleans, Louisiana, and centered on
state–of–the art scientific advances for cardiovascular
medicine and biology.

Dr. Peter Rabinovitch, University of Washington, first
introduced Bendavia during the Longevity and Caloric Restriction
Session demonstrating its potential as a therapy for cardiac
hypertrophy and heart failure within several cardiovascular animal
models. Later, Dr. Robert Kloner's laboratory, led by Sharon Hale,
Heart Institute of Good Samaritan Hospital, presented animal data
on Bendavia for acute myocardial infarction (AMI) and its ability
to preserve viable and compromised myocardium after ischemia
reperfusion injury, while independently reducing the area of
microvascular dysfunction associated with the often termed
“no–reflow” phenomenon. The no–reflow
phenomenon was originally described by Dr. Kloner more than three
decades ago and more recently has been shown to be an independent
determinant of mortality and morbidity for AMI patients.

The initial clinical program for Bendavia is the treatment of
ischemia reperfusion and microvascular injuries, common
complications of interventional procedures for AMI, coronary bypass
surgery and renal transplantation. Standard animal models for such
interventional procedures including those presented by Dr. Kloner's
laboratory demonstrate Bendavia's beneficial biologic effects and
confirm the significance of its novel mechanism of action, which
preserves mitochondrial function under pathological conditions, for
ischemia reperfusion and microvascular injuries.

Contrary to prior therapeutic strategies for ischemia
reperfusion injury and AMI that focused on uni–targeted
pathways, Bendavia and its mitochondria–directed actions
address the more complicated, multifactorial nature of diseases.
Specifically, Bendavia appears to maintain electron transport chain
efficiencies under substantial oxidative stress, thereby preserving
mitochondrial respiration and adenosine triphosphate levels and
preventing mitochondrial swelling and depolarization. Bendavia also
appears to be a strong neurologic and renal protectant in
preclinical models, which holds promise as a treatment for stroke
and renally impaired patients.

Stealth's CEO, Travis Wilson, remarked, “Stealth is
enthusiastic about the recognition of Bendavia as a novel candidate
for such common cardiovascular diseases as AMI and heart failure.
Based on the successful conclusion of our Phase I clinical trials
and encouraging preclinical data for several chronic and acute
conditions, we feel that Bendavia has the potential to be a
significant advancement to the treatment of cardio–renal,
neurologic and metabolic disorders including rare and orphan
related diseases.”

Statistics from the AHA indicate that more than 600,000 people
within the U.S. die from heart disease and AMI each year, an amount
greater than the combined total of mortalities from every type of
cancer. As background, ischemia is defined as the inadequate supply
of oxygen and nutrients to maintain normal cellular aerobic
metabolism. It arises primarily from a lack of blood flow to tissue
and is seen in a variety of clinical conditions including stroke,
AMI, acute and chronic kidney injury and organ transplantation. In
tissues with high metabolic activity, such as the brain and heart,
adenosine triphosphate stores are depleted within the first few
minutes of ischemia. Standard–of–care reperfusion
therapies for AMI include primary percutaneous coronary
intervention and thrombolysis. Prompt restoration of blood flow to
the ischemic myocardium limits infarct size, which is a major
determinant of mortality and morbidity for AMI patients.
Paradoxically, the return of blood flow after ischemia can also
result in additional cardiac damage and complications. This
phenomenon known as reperfusion injury is associated with an array
of myocardial, vascular and electrophysiological derangements that
can increase infarct size and cause long–term clinical
deterioration and complications including heart failure. To date,
effective therapies to reduce or prevent reperfusion injury have
proven elusive. Through its mitochondria–directed actions,
Bendavia appears to be a lead candidate for innovative
pharmacologic approaches to reduce ischemia reperfusion and
microvascular injuries in patients.

About Stealth Peptides

Stealth has a rich and promising pipeline of preclinical and
clinical compounds from a unique class of short peptides
(500–700 Daltons each) that target mitochondria. Published,
peer–reviewed data for these compounds suggest significant
in vitro and in vivo efficacy for metabolic,
ophthalmologic, neurologic and cardio–renal related
disorders. The intellectual property portfolio around these
compounds is exceptionally robust with compositions, including
Bendavia, protectable by patent until 2031.

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